Study to Compare Efficacy and Safety of Daptomycin in Elderly Patients With Complicated Skin and Soft Tissue Infections

NCT ID: NCT01184872

Last Updated: 2012-07-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-03-31
• Study Completion Date: 2011-03-31

Brief Summary

The purpose of this study is to provide data documenting the efficacy of daptomycin in elderly patients aged ≥ 65 years with complicated Skin and Soft Tissue Infections.

Conditions

Infections

Keywords

Skin infection; Daptomycin; Elderly; Gram positive; Complicated skin and soft tissue infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Daptomycin

Patients with bacteremia: Daptomycin 6 mg/Kg intravenous once daily for at least 5 days and up to 28 days.

Patients without bacteremia: Daptomycin 4 mg/Kg intravenous once daily for at least 5 days and up to 14 days.

Group Type: EXPERIMENTAL

Daptomycin

Intervention Type: DRUG

Patients with bacteremia: Daptomycin 6 mg/Kg intravenous once daily for at least 5 days and up to 28 days.

Patients without bacteremia: Daptomycin 4 mg/Kg intravenous once daily for at least 5 days and up to 14 days.

Vancomycin or Semi-Synthetic Penicillins (SSPs)

Patients with bacteremia: Vancomycin 1 g intravenous twice daily or Semi-Synthetic Penicillins 2 g intravenous every 4 hours for at least 5 days and up to 28 days.

Patients without bacteremia: Vancomycin 1 g intravenous twice daily or Semi-Synthetic Penicillins 2 g intravenous every 6 hours for at least 5 days and up to 14 days.

Group Type: ACTIVE_COMPARATOR

Vancomycin or Semi-Synthetic Penicillins (SSPs)

Intervention Type: DRUG

Patients with bacteremia: Vancomycin 1 g intravenous twice daily or Semi-Synthetic Penicillins 2 g intravenous every 4 hours for at least 5 days and up to 28 days.

Patients without bacteremia: Vancomycin 1 g intravenous twice daily or Semi-Synthetic Penicillins 2 g intravenous every 6 hours for at least 5 days and up to 14 days.

Interventions

Daptomycin

Patients with bacteremia: Daptomycin 6 mg/Kg intravenous once daily for at least 5 days and up to 28 days.

Patients without bacteremia: Daptomycin 4 mg/Kg intravenous once daily for at least 5 days and up to 14 days.

Intervention Type: DRUG

Vancomycin or Semi-Synthetic Penicillins (SSPs)

Patients with bacteremia: Vancomycin 1 g intravenous twice daily or Semi-Synthetic Penicillins 2 g intravenous every 4 hours for at least 5 days and up to 28 days.

Patients without bacteremia: Vancomycin 1 g intravenous twice daily or Semi-Synthetic Penicillins 2 g intravenous every 6 hours for at least 5 days and up to 14 days.

Intervention Type: DRUG

Other Intervention Names

Oxacillin,; Cloxacillin,; Flucloxacillin,

Eligibility Criteria

Inclusion Criteria

Patients 65 years or older with infection of sufficient severity to require in-patient hospitalization, with parenteral antimicrobial therapy for at least 96 hours.

Patients who have a diagnosis of Gram-positive complicated Skin and Soft Tissue Infections (cSSTIs) with or without bacteremia:

• Wound infections,
• Major abscesses with or without recognized preceding trauma, that require antibiotic therapy in addition to surgical incision and drainage,
• Severe carbunculosis,
• Infected ulcers (except patients with multiple infected ulcers) associated with: diabetes, vascular insufficiency, pressure (i.e., decubitus ulcers).

Exclusion Criteria

Conditions requiring surgery that in and of itself would cure the infection or remove the infected site (e.g., amputation).

Minor or superficial skin infections (e.g., furuncles, simple abscesses, acne, impetigo).

Cellulitis, including erysipelas, not associated with complicating factors. However, patients with cellulitis associated with more serious infection (e.g., surgical wound, diabetic ulcer, deep tissue) can be enrolled (proportion of these patients will be limited to 30%).

Infections for which outcome is difficult to assess:

• Perirectal abscess,
• Hidradenitis suppurativa,
• Gangrene,
• Infected human or animal bites,
• Multiple infected ulcers at distant sites,
• Infected burns (only third degree burn wound or wound area of more than 10 cm diameter),
• Conditions requiring emergency surgery including necrotizing fasciitis.

Medical conditions:

• History of significant allergy or intolerance to Vancomycin or Daptomycin. Hypersensitivity to SSPs penicillins is not an exclusion criterion,
• Concomitant clinically suspected or confirmed other site of infection or disorder at study entry that may interfere with the evaluation in this protocol,
• Infections associated with a permanent prosthetic device that will not be removed within 24 hours after enrolment,
• Known or suspected HIV infection with a CD4+ T-cell count < 500/μL (HIV testing is not required),
• Severe hepatic disease (Child-Pugh Class C) or ALT and/or AST > 5 times ULN and/ or total bilirubin > 2 times ULN at screening,
• Calculated creatinine clearance by the Cockcroft-Gault equation using actual body weight < 30 mL/min or any type of dialysis,
• Treatment with any investigational agent or device within 30 days of study drug administration.

• Previous systemic antibacterial therapy for the treatment of Gram-positive complicated skin and soft tissue infections for more than 24 hours within 48 hours prior to the day of first infusion of study drug unless:
• The previous antibacterial therapy was administered for 3 or more calendar days with either worsening or no improvement in the clinical signs and symptoms of cSSTIs, and was not Vancomycin or SSPs.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Pharmceuticals

Role: STUDY_DIRECTOR

Novartis Pharmceuticals

Locations

Novartis Investigative Site

Graz, , Austria

Novartis Investigative Site

Vienna, , Austria

Novartis Investigative Site

Bochum, , Germany

Novartis Investigative Site

Essen, , Germany

Novartis Investigative Site

Homburg, , Germany

Novartis Investigative Site

Magdeburg, , Germany

Novartis Investigative Site

Mannheim, , Germany

Novartis Investigative Site

Münster, , Germany

Novartis Investigative Site

Tübingen, , Germany

Novartis Investigative Site

Pisa, , Italy

Novartis Investigative Site (1)

Moscow, , Russia

Novartis Investigative Site

Novosibirsk, , Russia

Novartis Investigative Site (2)

Saint Petersburg, , Russia

Novartis Investigative Site

Yaroslavi, , Russia

Novartis Investigative Site (1)

Madrid, , Spain

Novartis Investigative Site

Santander, , Spain

Novartis Investigative Site

Seville, , Spain

Countries

Austria; Germany; Italy; Russia; Spain

References

Arbeit RD, Maki D, Tally FP, Campanaro E, Eisenstein BI; Daptomycin 98-01 and 99-01 Investigators. The safety and efficacy of daptomycin for the treatment of complicated skin and skin-structure infections. Clin Infect Dis. 2004 Jun 15;38(12):1673-81. doi: 10.1086/420818. Epub 2004 May 20.

Reference Type: BACKGROUND

PMID: 15227611 (View on PubMed)

Other Identifiers

2009-014391-22

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CCBC134A2404

Identifier Type: -

Identifier Source: org_study_id